510(k) · Cleared
Recalled · Class III · 2014Devilbiss Intellipap Model DV 5 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 7, 2007 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 7, 2007
- Review
- 79 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK071689 Devilbiss Intellipap Model DV 5 SeriesSunrise Medical · 2007
- Descendant · cites it directly · 1 of its ownK091919 Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK143677 DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC · 2015
- Descendant · cites it directly · 0 of its ownK112220 Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK093070 Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical · 2010
Most influential descendants
Showing 4 of 4 · See all- K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical · 2009 · cites it directly1descendant
- K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC · 2015 · cites it directly0descendants
- K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC · 2011 · cites it directly0descendants
- K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071689 | Devilbiss Intellipap Model DV 5 Series | Sunrise Medical | 2007 | — |
| +1 | K091919 | Devilbiss Intellipap/Sleepcube Bilevel S/ST | Sunrise Medical | 2009 | 1 |
| +1 | K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | Devilbiss Healthcare, LLC | 2015 | — |
| +1 | K112220 | Devilbiss Intellipap / Sleepcube Auto Bilevel | Devilbiss Healthcare, LLC | 2011 | 1 |
| +1 | K093070 | Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST Series | Sunrise Medical | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2014 | Class III | Z-1949-2014 | Software Manufacturing/Software Deployment | A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST". |
| Mar 11, 2011 | Not classified | Z-2990-2011 | Nonconforming Material/Component | Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091919 (Sunrise Medical, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The DeVilbiss IntelliPAP Model DV5 Series is intended for use in
treating obstructive sleep apnea in patients 30 Kg and above.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K071689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071689: Devilbiss Intellipap Model DV 5 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026